Events

Recall of Device Recall 5mm X 30cm Hollow "Golf" Tip Ultrasonic Aspiration Probe

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Mentor Texas, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    38623
  • Event Risk Class
    Class 3
  • Event Number
    Z-1230-2007
  • Event Initiated Date
    2007-07-27
  • Event Date Posted
    2007-09-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-04-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=54057
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Ultrasonic Aspiration Probe - Product Code MUU
  • Reason
    Mis-identified and mis-labeled surgical probes were distributed. 5mm x 30cm hollow "golf" tip ultrasonic aspiration probe, model 5620-530, catalog number 5620-530 was shipped, instead of lysonix 5mm x 30cm hollow bullet tip ultrasonic probe, catalog number 5610-530.
  • Action
    Firm notified consignees by letter on July 27, 2007.

Device

Device Recall 5mm X 30cm Hollow "Golf" Tip Ultrasonic Aspiration Probe
  • Model / Serial
    Serial numbers: 0028-05, 0035-05, 0069-05, and 0092-05
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, including VA, IN, CA, and IL.
  • Product Description
    5mm x 30cm Hollow "Golf" Tip Ultrasonic Aspiration Probe, Model 5620-530, Catalog Number 5620-530.
  • Manufacturer
    Mentor Texas, Inc

Manufacturer

Mentor Texas, Inc
  • Manufacturer Address
    Mentor Texas, Inc, 3041 Skyway Cir N, Irving TX 75038-3500
  • Source
    USFDA